Catalog Number

-

Brand Name

LOOKEE

Version/Model Number

PL-029K30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200561,K200561

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

b0173847-401a-4665-aa3a-6c438cb07cde

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 11, 2021

Package DI Number

10628176949212

Quantity per Package

1

Contains DI Package

00628176949215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-